CATO SMS Thought Leadership

CATO SMS Thought Leadership

  • New FDA Gudiances for August 2020 and Upcoming…
    by Cato Research on September 3, 2020 at 12:07 pm

    By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Draft Guidance for […]

  • New FDA Gudiances for July 2020 and Upcoming…
    by Cato Research on August 5, 2020 at 7:46 pm

      By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Final Guidance 31 Jul 2020 […]

  • Are you ready for the new European clinical trial…
    by Cato Research on July 20, 2020 at 7:07 pm

    29 June 2020 – Cleo François MSc, Regulatory Affairs Manager The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make […]

  • New FDA Gudiances for June 2020 and Upcoming…
    by Cato Research on July 5, 2020 at 9:53 pm

    By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry – Final Guidance 30 Jun 2020 Review and Update of Device Establishment […]

  • New FDA Gudiances for May 2020 and Upcoming…
    by Cato Research on June 8, 2020 at 8:06 pm

    By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) – Final Guidance 28 May 2020 Required Warnings for Cigarette Packages and […]